Ensuring effective quality management reviews – Five practices to adopt and avoid

Antiksha Joshi Date published: Nov 21, 23

In recent years, the role of senior management in defining and establishing a quality management system (QMS) has gained prominence. While management responsibilities around QMS have been clearly defined by the ISO 9000 series of quality standards since the 1980s, this concept was adopted much later by the regulated industries—such as pharmaceuticals, life sciences, and medical devices. Periodic quality management reviews are one way in which leadership teams can fulfill this responsibility.

While most regulated industries conduct these reviews at least annually, they continue to struggle with sustained compliance, improvements, and cultural challenges. In this article, I will share insights into common, ineffective quality management review practices and how utilizing quality tools like eQMS can yield better outcomes.

Avoid the "tick-box" approach in quality management reviews

Quality management reviews (QMR) often become mere "tick-box" activities, where the reviews and agenda items are not aligned with business goals. While a discussion of common QMS elements—such as deviations, CAPAs, change controls, training, risks, etc.—provides insight into the health of quality systems, it's essential to tailor the agenda for each meeting. This can be achieved by including topics based on trends, customer responses, and employee feedback.

Additionally, the frequency of quality management reviews should be revised according to current business needs and changes. For instance, if an organization has recently implemented a new manufacturing facility or line, the frequency of quality management reviews should increase to assess the effectiveness of implemented systems and the need for any changes.

Address KPIs and non-compliances holistically

Key Performance Indicator (KPI) data and non-compliances are often reviewed in silos. Typically, action plans are created to address non-compliant KPIs, but these solutions may serve as quick fixes without addressing underlying root causes.

The actions are often seen as the responsibility of the business function that experienced the major non-compliance. For example, the most common KPI tracks the number of human error-related deviations. Most quality management reviews discuss this KPI and identify which department had the greatest number of such deviations, assigning actions to address it. However, a more beneficial approach would be to understand why human errors occur—could they be due to unclear SOPs, lack of training, inadequate resources, or incorrect location of equipment/documents? Addressing these root causes is essential for effective management reviews.

Additionally, it's important for senior management to discuss out-of-trend data regarding KPIs. By doing so, potential issues can be identified and necessary actions can be taken before they escalate into compliance problems. Generating customizable reports through an eQMS tool is a good way to review relevant data.

Improve communication and tracking for effective management reviews

Quality management review discussions and outcomes often suffer from poor communication and tracking. In many organizations, the quality manager or head of quality generates a post-review report with a list of action items, which is circulated to different functional heads with the understanding that any actions identified for their function will be completed in the agreed time.

This process may work for small organizations with few team members, but problems arise when the organization grows, more employees are onboarded, and the number of actions is large. Actions often remain undone due to competing priorities, only being addressed in the next quality management review meeting. Further, multiple individuals may work in silo to address the same action.

Utilizing tools such as the task/action generation module of an eQMS, or automated workflows if available, can help break down communication silos and track actions. Actions are logged into the system, responsible individuals assigned, and target dates set. This provides clarity for all involved and enables real-time tracking of action status by functional managers.

Enhance employee awareness for sustained compliance

The performance and effectiveness of an implemented QMS—identified in quality management reviews and everyday data—must be communicated clearly to employees to maintain sustained compliance. Senior leadership holds the responsibility of effectively communicating the message and expectations around quality. Following quality management reviews, employees are informed of the outcome through an email with a lengthy report attached. While transparent, this can leave employees unable to gauge the system's health or understand major issues.

A more effective method is to employ visual dashboards (commonly available in many eQMS tools) that highlight data from KPIs, customer feedback, compliance, etc. This data is readily available for employees to view at their own pace and can be customized for easier comprehension.

Next steps in improving quality management reviews

As regulatory focus shifts toward a holistic quality approach, the role of senior management in establishing effective, customized, and compliant quality systems becomes increasingly important. To fulfill this responsibility effectively, leadership teams must adapt and change their approach to conducting management reviews. Focusing on trends—such as new technology, data, regulatory, risks, training—is more crucial than merely reviewing non-compliances. Leveraging technology for better data collection, tracking, and analysis can lead to more effective management reviews.

Interested in how our quality management software can help take your quality management reviews to the next level? Learn more about Ideagen Quality Management today.

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